Sandra G. Adams, MD, MS; Jay I. Peters, MD
Is amoxicillin plus clavulanate effective for moderate exacerbations of mild-to-moderate chronic obstructive pulmonary disease (COPD)?
Randomized placebo-controlled trial (RCT). ClinicalTrials.gov NCT00495586.
{Concealed}*.†
Blinded† (patients, investigators, {health care providers, data collectors, and data analysts}*).
9 to 11 days, 20 days, and 1 year.
13 primary care centers in Catalonia, Spain.
318 outpatients ≥ 40 years of age (mean age 68 y, 81% men) who had an exacerbation (≥ 1 of increased dyspnea, increased sputum volume, or sputum purulence) of mild-to-moderate COPD (≥ 10 pack-y smoking history, postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 > 50% of predicted value). Exclusion criteria included need for hospitalization; antibiotic use in the past 2 weeks; hypersensitivity to β-lactams, clavulanate, or lactose; immunosuppression; bronchial asthma; cystic fibrosis; active neoplasm; bronchiectasis due to conditions other than COPD; or tracheotomy.
Amoxicillin/clavulanate, 500/125 mg (n = 162), or placebo (n = 156), 3 times/d for 8 days. Oral corticosteroids (≤ 60 mg/d) for ≤ 10 days could be used in both groups.
Primary outcome was clinical cure (disappearance of infection-related acute signs and symptoms and return to stability) at 9 to 11 days. Other outcomes included clinical success (cure or improvement [incomplete symptom resolution without need for another medication or intervention]) and time to next exacerbation.
97% (intention-to-treat analysis).
Oral corticosteroids were used in 16% of patients in the amoxicillin group and 18% in the placebo group. Amoxicillin/clavulanate increased clinical cure and clinical success rates at 9 to 11 days and at 20 days compared with placebo (Table). Time to next exacerbation was longer with amoxicillin/clavulanate than with placebo (median 233 vs 160 d, P = 0.015).
Amoxicillin/clavulanate improved clinical cure rate and increased time to next exacerbation compared with placebo in patients with moderate exacerbation of mild-to-moderate chronic obstructive pulmonary disease.
Amoxicillin/clavulanate (AMX) vs placebo for moderate exacerbations of mild-to-moderate chronic obstructive pulmonary disease‡
‡Abbreviations defined in Glossary. RBI, NNT, and CI calculated from event rates in article.
§Disappearance of infection-related acute signs and symptoms and return to stability.
||Cure or improvement (incomplete symptom resolution without need for another medication or intervention).
Adams SG, Peters JI. Amoxicillin/clavulanate vs placebo: more exacerbation cures, fewer recurrences in mild-to-moderate COPD. Ann Intern Med. 2013;158:JC3. doi: 10.7326/0003-4819-158-6-201303190-02003
Download citation file:
© 2019
Published: Ann Intern Med. 2013;158(6):JC3.
DOI: 10.7326/0003-4819-158-6-201303190-02003
Chronic Obstructive Airway Disease, Pulmonary/Critical Care.
Results provided by: